Drug abuse is a major public health concern that impacts society on multiple levels. Alcohol, tobacco, and illegal drug use are pervasive throughout the world. Substance abuse problems are among the major contributors to the global disease burden, which includes disability and mortality. The main health consequences of drug misuse are the development of cardiovascular diseases, cancer, an increased likelihood of contracting HIV, hepatitis, and other infectious diseases and neurological effects. The harmful use of alcohol results in the death of 3.3 million people annually, while tobacco kills up to half of its users, which is more than 7 million people each year (including both smokers and nonsmokers, via second-hand smoking).
Drugs of abuse (including alcohol) are inherently rewarding. As an example, cocaine can lead to a euphoric state, energetic feelings, talkative dispositions and mental alertness. Cocaine helps them perform simple physical and intellectual tasks more quickly. Heroin produces a sense of well-being and euphoria. Nicotine improves concentration, attention and memory, and reduces reaction times. These effects are the motivation to be consumed by humans or self-administered by laboratory animals.
Repeated use of such drugs usually leads to tolerance and dependence, conditions in which progressively higher doses are required to maintain initial drug effectiveness and in which abrupt drug abstinence results in a large withdrawal syndrome. In the case of heroin, withdrawal involves thermoregulatory problems (chills and sweats), gastrointestinal (cramps, diarrhea) disturbances and significant painful dysphoria. When the drug is cocaine, the effects include dysphoria (mild depression), fatigue, sleep disturbances, increased appetite and anxiety. Nicotine withdrawal includes dysphoria, insomnia, anxiety, restlessness, decreased heart rate and weight gain.
Drug addiction is a complex disease involving changes in the brain as well as a wide range of social, familial, and other environmental factors. The benefits of treatment far outweigh the economic costs. Despite the availability of treatment services, however, the vast majority of people with substance use disorders do not seek or use treatment. Problems require combined research and policy-making efforts from all parts of the world to establish a viable knowledge base to inform for prevention, risk-reduction intervention, effective use of evidence-based treatment, and rehabilitation for long-term recovery.
Presently, there are no medications approved by the U.S. Food and Drug Administration to treat cocaine addiction, though researchers are exploring a variety of neurobiological targets.
The use of opioid-agonist medications such as methadone and buprenorphine for opioid addiction has led to the misconception that such drugs are just substitutes for the opioid being abused. Although these medications are opioid agonists, their slower brain pharmacokinetics along with their more stable concentrations help to stabilize physiologic processes that are disrupted by intermittent abuse of opioids. The use of these drugs also protects against risks associated with opioid abuse while facilitating recovery. However, treatment for opioid dependence is not always available due to a limited number of providers, waiting lists to access treatment, or laws that prevent their use.
The first pharmacological treatments approved by the U.S. Food and Drug Administration for smoking cessation were nicotine replacement therapies (NRTs), such as nicotine gum and a transdermal nicotine patch. One benefit of these therapies is that these forms of nicotine have little abuse potential since they do not produce the pleasurable effects of tobacco products, nor do they contain the carcinogens and gases associated with tobacco smoke. When NRTs are used in conjunction with behavioral support, the treatment successful is bigger. However, whereas nicotine gum provides some smokers with the desired control over dose and the ability to relieve cravings, others are unable to tolerate the taste and chewing demands. Skin reactions are one of the more common side-effects of nicotine patches. Other treatments are also available, such as Varenicline tartrate (Chantix), which is a medication that also received FDA approval for smoking cessation. Varenicline and combination nicotine replacement therapy (C-NRT) are the most efficient conventional therapies, but Varenicline produces significant adverse events like vivid dreams, insomnia, nausea, constipation, sleepiness, and indigestion. In any case, quitting smoking has been found to be very difficult. Within 6 months, 75-80 percent of people who try to quit smoking relapse.
The neurobiology underlying drug abuse has led to the recognition of addiction as a chronic disease of the brain. Therefore, additional treatment options are needed to combat this disease without the drawbacks and disadvantages associated with current methods. Such treatment options should be readily available, easy to use, cost effective, safe and effective. At least some of these objectives will be met by the present invention.